Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Medicine and Pharmacy "Victor Babes" Timisoara | OTHER |
Not provided
Not provided
Not provided
Not provided
Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.
This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused |
|
| Control arm | No Intervention | In the control arm, patients will receive standard COVID-19 treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic plasma exchange | Other | The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Number of Participants who Survived | 30 day period |
| Measure | Description | Time Frame |
|---|---|---|
| P/F Ratio | Average Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio - P/F ratio calculated between the values from day 1 and day 7 | 7 day period |
| C Reactive Protein (CRP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monica Licker, MD, PhD | University of Medicine and Pharmacy "Victor Babes" Timisoara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Hospital "Dr. Teodor Andrei" Lugoj | Lugoj | Timiș County | 305500 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34934447 | Derived | Novacescu AN, Duma G, Buzzi B, Baditoiu LM, Bedreag O, Papurica M, Sandesc D, Sorescu T, Vlad D, Licker M. Therapeutic plasma exchange followed by convalescent plasma transfusion in severe and critically ill COVID-19 patients: A single centre non-randomized controlled trial. Exp Ther Med. 2022 Jan;23(1):76. doi: 10.3892/etm.2021.10999. Epub 2021 Nov 24. |
| Label | URL |
|---|---|
| World Health Organization. WHO Coronavirus (COVID-19) Dashboard. Geneva: 2021 | View source |
Not provided
We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data
Data will become available at 6 months after registering the study. It will be available for 36 months
Data will be shared with interested researchers, contact: novacescu_alex@yahoo.com
Not provided
All patients included in the study were adults (>18 years) who presented with acute respiratory failure and ARDS, had positive reverse transcriptase-polymerase chain reaction (RT-PCR) test results for SARS-CoV-2 virus and presented with clinical and/or radiological signs of COVID-19 pneumonia upon hospital admission. Exclusion criteria were represented by any of the following: Pregnancy, patients with suspected or confirmed pulmonary embolisms and patients with terminal disease.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2020 |
Not provided
Single group, that is divided into two arms
Not provided
Not provided
Not masked
|
Average value of CRP calculated using the values from day 1 and day 7
| 7 day period |
| Lactate Dehydrogenase (LDH) | Average value of LDH calculated using the values from day 1 and day 7 | 7 day period |
| Ferritin | Average value of ferritin calculated using the values from day 1 and day 7 | 7 day period |
| Lin L, Li TS. \[Interpretation of "Guidelines for the diagnosis and treatment of novel coronavirus (2019-nCoV) infection by the national health commission (Trial Version 5)" \]. Zhonghua Yi Xue Za Zhi. 2020;100(0):E001 | View source |
| Franchini M, Liumbruno GM. Convalescent plasma for the treatment of severe COVID-19. Biol Targets Ther. 2021;15:31-38 | View source |
| Keith P, Day M, Perkins L, Moyer L, Hewitt K, Wells A. A novel treatment approach to the novel coronavirus: an argument for the use of therapeutic plasma exchange for fulminant COVID-19. Crit Care. 2020;24(1):1-3 | View source |
| Gucyetmez B, Atalan HK, Sertdemir I, et al. Therapeutic plasma exchange in patients with COVID-19 pneumonia in intensive care unit: a retrospective study. Crit Care. 2020;24(1):1-4 | View source |
| Sarfraz A, Singh-Makkar S, Sarfraz Z, et al. Therapeutic plasma exchange and COVID-19: a rapid review. Clin Immunol Immunother. 2020;6(4):1-5 | View source |
| Kamran SM, Mirza ZE, Naseem A, et al. Therapeutic plasma exchange for coronavirus disease-2019 triggered cytokine release syndrome; a retrospective propensity matched control study. PLoS One. 2021;16(1 January):e0244853 | View source |
| Liu S, Lin H-M, Baine I, et al. Convalescent plasma treatment of severe COVID-19: a matched control study. Nat Med. 2020;26(11):1708-1713 | View source |
| Stahl K, Bode C, David S. First do no harm - beware the risk of therapeutic plasma exchange in severe COVID-19. Crit Care. 2020;24(1):1-2 | View source |
| Honore PM, Barreto Gutierrez L, Kugener L, et al. Plasma exchange in critically ill COVID-19 patients improved inflammation, microcirculatory clot formation, and hypotension, thereby improving clinical outcomes: Fact or fiction? Crit Care. 2020;24(1):1-2 | View source |
| Wang EY, Mao T, Klein J, et al. Diverse functional autoantibodies in patients with COVID-19. Nature. 2021;595:283-288 | View source |
| Fajnzylber J, Regan J, Coxen K, et al. SARS-CoV-2 viral load is associated with increased disease severity and mortality. Nat Commun. 2020;11(1):1-9 | View source |
| FG001 | Control Arm | In the control arm, patients will receive standard COVID-19 treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 |
| BG001 | Control Arm | In the control arm, patients will receive standard COVID-19 treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Comorbidities present | Number | participants |
| ||||||||||||||||||
| Symptoms onset to treatment | Mean | Standard Deviation | Days |
| |||||||||||||||||
| Acute Physiology and Chronic Health Evaluation (APACHE II) | The APACHE II score can be used to describe the morbidity of a patient when comparing the outcome with other patients. The APACHE II score ranges from 0 to 71 points. Increasing score is associated with increased mortality. | Mean | Standard Deviation | points |
| ||||||||||||||||
| Severe form of COVID-19 | The 'Guidelines for the Diagnosis and Treatment of Novel Coronavirus (2019-nCoV) Infection by the [Chinese] National Health Commission (Trial Version 5)' clinically distinguishes four levels of severity: Mild, common, severe and critical | Count of Participants | Participants |
| |||||||||||||||||
| Critical form of COVID-19 | The 'Guidelines for the Diagnosis and Treatment of Novel Coronavirus (2019-nCoV) Infection by the [Chinese] National Health Commission (Trial Version 5)' clinically distinguishes four levels of severity: Mild, common, severe and critical | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Number of Participants who Survived | Posted | Count of Participants | Participants | 30 day period |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | P/F Ratio | Average Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio - P/F ratio calculated between the values from day 1 and day 7 | Posted | Mean | Standard Deviation | ratio | 7 day period |
|
| ||||||||||||||||||||||||||||||
| Secondary | C Reactive Protein (CRP) | Average value of CRP calculated using the values from day 1 and day 7 | Posted | Mean | Standard Deviation | mg/l | 7 day period |
|
| ||||||||||||||||||||||||||||||
| Secondary | Lactate Dehydrogenase (LDH) | Average value of LDH calculated using the values from day 1 and day 7 | Posted | Mean | Standard Deviation | U/l | 7 day period |
|
| ||||||||||||||||||||||||||||||
| Secondary | Ferritin | Average value of ferritin calculated using the values from day 1 and day 7 | Posted | Mean | Standard Deviation | micrograms/l | 7 day period |
|
|
1 month
Data regarding adverse event collection was obtained by the continuous monitoring of vital signs specific for the intensive care unit. During the treatment proposed in the intervention arm of this trial, a physician was supervising the vital signs of the patient to immediately stop the treatment in the event of an adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 | 10 | 19 | 1 | 19 | 0 | 19 |
| EG001 | Control Arm | In the control arm, patients will receive standard COVID-19 treatment | 14 | 19 | 0 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Cardiac disorders | Systematic Assessment | 1 patient in the treatment group presented with transient hypotension (systolic blood pressure <90 mmHg) after the transfusion of convalescent plasma, which resolved upon administration of crystalloid bolus. |
|
Not provided
Limitations of the study include the small number of patients enrolled and the non-randomized nature of the study. Also antibody titer was not determined in patients prior to the treatment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Novacescu Alexandru | University of Medicine and Pharmacy "Victor Babes" Timisoara | +40745064844 | novacescu_alex@yahoo.com |
| Nov 29, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|